Heidegger Thomas, Starzyk Lukas, Villiger Cornelia R, Schumacher Stefan, Studer Rolf, Peter Barbara, Nuebling Matthias, Gerig Hans J, Schnider Thomas W
Department of Anaesthesia, Spitalregion Rheintal Werdenberg Sarganserland, Walenstadt, Switzerland.
Anesthesiology. 2007 Oct;107(4):585-90. doi: 10.1097/01.anes.0000281925.61143.b5.
Tracheal intubation with neuromuscular blocking agents is associated with a low incidence of minor vocal cord sequelae (8%). The aim of this noninferiority trial was to demonstrate that the frequency of vocal cord sequelae after fiberoptic intubation with a flexible silicone tube without neuromuscular blocking agents was less than 25% (maximum tolerable inferiority).
Two-hundred seventy patients were prospectively randomized to two groups. All intubations were performed by anesthesiologists with extensive experience in fiberoptic and conventional techniques. Fiberoptic nasotracheal intubation consisted of a bolus dose of 2 microg/kg fentanyl; 0.25 ml cocaine instillation, 10%, into nasal canals; cricothyroid injection of 2 ml lidocaine, 1%; bronchoscopy; administration of 0.3 mg/kg etomidate; and advancing a flexible silicone tube after loss of consciousness. Orotracheal intubation was performed with a polyvinyl chloride tube after induction with 2 microg/kg fentanyl, 2 mg/kg propofol, and 0.6 mg/kg rocuronium. Patients were examined by laryngoscopy before surgery, 24 h after surgery, and daily until complete restitution. Postoperative hoarseness was assessed by a standardized interview.
The incidence of vocal cord sequelae was 11 out of 130 (8.5%) in the fiberoptic group versus 12 out of 129 (9.3%) in the control group (chi-square = 0.057, df = 1, P = 0.81; upper limit of the one-sided 95% confidence interval for the difference: +5.1%). There were no persistent injuries. The incidence of postoperative hoarseness was 4% in both groups.
Because fiberoptic intubation without neuromuscular blocking agents is safe regarding vocal cord sequelae, routine use is justified for anesthesiologists experienced in this technique.
使用神经肌肉阻滞剂进行气管插管时,声带轻微后遗症的发生率较低(8%)。这项非劣效性试验的目的是证明,在不使用神经肌肉阻滞剂的情况下,使用柔性硅胶管进行纤维支气管镜插管后声带后遗症的发生率低于25%(最大可耐受劣效性)。
270例患者被前瞻性随机分为两组。所有插管均由在纤维支气管镜和传统技术方面有丰富经验的麻醉医生进行。纤维支气管镜经鼻气管插管包括静脉推注2μg/kg芬太尼;向鼻道内滴注0.25ml 10%的可卡因;环甲膜注射2ml 1%的利多卡因;支气管镜检查;静脉注射0.3mg/kg依托咪酯;意识消失后插入柔性硅胶管。经口气管插管是在静脉注射2μg/kg芬太尼、2mg/kg丙泊酚和0.6mg/kg罗库溴铵诱导后,使用聚氯乙烯管进行。术前、术后24小时以及每天进行喉镜检查,直至完全恢复。通过标准化访谈评估术后声音嘶哑情况。
纤维支气管镜组130例中有11例(8.5%)出现声带后遗症,而对照组129例中有12例(9.3%)出现声带后遗症(卡方检验=0.057,自由度=1,P=0.81;差异的单侧95%置信区间上限:+5.1%)。没有持续性损伤。两组术后声音嘶哑的发生率均为4%。
由于在不使用神经肌肉阻滞剂的情况下进行纤维支气管镜插管对声带后遗症是安全的,对于有此技术经验的麻醉医生来说,常规使用是合理的。